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FDA 510(k)

The VEGA Cervical Screw System

K-Number: K254260 · 2026-09-17

ApplicantGS Medical Co., Ltd.
Decision Date2026-09-17
Product CodeNKG
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

The VEGA Cervical Screw System is the device name listed in this FDA 510(k) record. The listed applicant is GS Medical Co., Ltd.. It received FDA 510(k) clearance on 2026-09-17 under 510(k) number K254260. The device is classified under product code NKG. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the The VEGA Cervical Screw System?

The VEGA Cervical Screw System is a medical device that received FDA 510(k) clearance on 2026-09-17. The listed applicant is GS Medical Co., Ltd.. The 510(k) number is K254260.

When did The VEGA Cervical Screw System receive FDA 510(k) clearance?

The VEGA Cervical Screw System received FDA 510(k) clearance on 2026-09-17, under 510(k) number K254260.

Who is the listed applicant for The VEGA Cervical Screw System?

The FDA 510(k) record lists GS Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for The VEGA Cervical Screw System?

The FDA product code for The VEGA Cervical Screw System is NKG.

Other records listing GS Medical Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243073AnyPlus Navigated Instruments SystemK241738PYXIS 3D Titanium Cervical Cage systemK240350AnyPlus II Spinal Fixation SystemK231808QUASAR Standalone ACIF SystemK223868PYXIS 3D Titanium Cage SystemK222041CYGNUS-C Standalone ACIF System

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Related Devices (Code: NKG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253195TAURUS Posterior Occipital-Cervico-Thoracic Spinal SystemsZheJiang Decans Medical Devices Co., Ltd.K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw SystemCarboFix Orthopedics , Ltd.K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AGK253129Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.K251725ANAX™ OCT Spinal SystemCg Medtech Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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